Active Biotech

Regulatory Filings • Mar 23, 2016

Active Biotech plans to develop tasquinimod for the treatment of multiple myeloma

Lund, March 23, 2016 - Active Biotech (Nasdaq Stockholm: ACTI) today announces that a patent application for the treatment of multiple myeloma with the company's compound tasquinimod, together with an international search report, will be public within short on WIPO's (World Intellectual Property Organization) web site www.wipo.int. With this application (WO 2016/042112), treatment of multiple myeloma with tasquinimod is potentially protected until 2035. With the aim to expand the patent protection for tasquinimod, a preclinical program was performed and very good results were achieved in models for multiple myeloma. The existing medical need and the possibility for combination treatments makes tasquinimod, with its unique mode of action, a strong development candidate within this indication.

"The positive effect on progression free survival (PFS) in prostate cancer, together with the comprehensive safety documentation at hand, makes tasquinimod a potential future treatment alternative for multiple myeloma. The company will actively seek a collaboration partner for the development of tasquinimod within this indication", says Tomas Leanderson, CEO Active Biotech.

Approximately two out of ten thousand people are affected by multiple myeloma which means that candidate drugs for the treatment of this indication can receive orphan drug status. The orphan drug designation is implemented to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as lifethreatening or chronically debilitating. Orphan drug status gives easier access to regulatory advice, lower costs for market application as well as market exclusivity if the product is registered on the market. During 2016 orphan drug status applications for tasquinimod treatment of multiple myeloma are planned to be submitted to authorities in the EU and USA.

About multiple myeloma

Multiple myeloma is an incurable form of blood cancer where the plasma cells in the bone marrow grow uncontrollably while other blood forming cells such as white and red blood cells and blood platelets are suppressed. This leads to anemia, infections, destruction of bone tissue and kidney problems since normal plasma cells are an important part of the body's immune defense and the production of antibodies. Five year survival average is below 50 percent (National Institute of Health Surveillance Research Program 2005-2011). The total market for multiple myeloma drugs amounted to 7.8 billion USD in 2013 (GlobalData 2015).

Om tasquinimod

Tasquinimod is an immunomodulatory, anti-metastatic compound that indirectly affects the tumor's ability to grow and spread. The development of tasquinimod has previously been focused on the treatment of prostate cancer but this development was halted during 2015 after non-satisfactory results from a clinical Phase 3 trial.

The final results showed that tasquinimod treatment resulted in a prolonged radiographic progression-free survival (rPFS), 7.0 vs. 4.4 months (central assessment), similar to an earlier Phase 2 study. However, the positive effect on rPFS did not translate into an improved OS (HR 1.097, 95% CI: 0.938-1.282). Tasquinimod safety was in general manageable and similar to what was observed during the earlier Phase 2 study.

For further information, please contact:

Tomas Leanderson, President & CEO Tel +46 46 19 20 95

Active Biotech AB PO Box 724, SE-220 07 Lund Sweden Tel: +46 (0)46-19 20 00 Fax: +46 (0)46-19 11 00

Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal Phase 3 development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase 2 development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Furthermore, commercial activities are conducted for the ISI, ANYARA and paquinimod projects. Please visit www.activebiotech.com for more information.

Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. This information was provided to the media for publication at 8:30 am CET on March 23, 2016.